Often, early-development stage companies are working on pharmaceuticals and medical devices that have promising clinical intellectual property and commercial prospects. They may even have large pharma partners that help with financing and, eventually, submissions around the world. But in the beginning of trial phases they are often working with shoe-string budgets and simply trying to see if the innovative product will be efficacious.
The original data may be put into traditional table and listing format. In the early phase of development, providing the datasets in CDISC format is not typically done due to the added complexity and associated costs. But when these innovative companies realize that their product is headed for submission to the FDA, the team needs a way of integrating all their data. A case like this occurred in 2011, where the sponsor came back to SynteractHCR and asked for all of the initial datasets to be converted into CDISC format.